NCT04558892

Brief Summary

The primary objective is to test the hypothesis that enoxaparin efficacy is reduced in severe nephrotic syndrome. Another purpose is to compare two dosing regimens.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
Last Updated

January 30, 2023

Status Verified

September 1, 2020

Enrollment Period

3.2 years

First QC Date

September 10, 2020

Last Update Submit

January 26, 2023

Conditions

Nephrotic Syndrome

Keywords

Nephrotic syndromeEnoxaparinLow molecular weight heparinAnti-Xa activityAntifactor XaVenous thromboembolism

Outcome Measures

Primary Outcomes (2)

  • Therapeutic enoxaparin's anti-Xa activity in nephrotic syndrome.

    Anti-Xa activity values ≥ 0.3 IU/mL in the steady state of enoxaparin concentration, on average between days 3 and 5.

    Average: Day 3-5

  • Minimum threshold of enoxaparin's anti-Xa activity.

    Anti-Xa activity values ≥ 0.2 IU/mL in the steady state of enoxaparin concentration on average between days 3 and 5.

    Average: Day 3-5

Secondary Outcomes (5)

  • Severity of nephrotic syndrome.

    Day 0, Day 3-5

  • Coagulation system protein.

    Day 0, Day 3-5

  • Renal function.

    Day 0, Day 3-5

  • Edema.

    Day 0, Day 3-5

  • Overhydration.

    Day 3-5

Other Outcomes (2)

  • Venous thromboembolic events.

    Follow-up period of 1 year from enrollment.

  • Adverse events of enoxaparin.

    Follow-up period of 1 year from enrollment.

Study Arms (3)

Nephrotic syndrome - fixed dose (NS-FD)

EXPERIMENTAL

Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously.

Drug: Enoxaparin

Nephrotic syndrome - adjusted dose (NS-AD)

EXPERIMENTAL

Drug: Enoxaparin; Dose: 1 mg/kg of ideal body weight; Administration: once daily subcutaneously.

Drug: Enoxaparin

Control - fixed dose (C-FD)

ACTIVE COMPARATOR

Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously.

Drug: Enoxaparin

Interventions

EnoxaparinDRUG
Control - fixed dose (C-FD)Nephrotic syndrome - adjusted dose (NS-AD)Nephrotic syndrome - fixed dose (NS-FD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe NS, defined as proteinuria exceeding 3.5 g/24h or 50 mg/kg/24h and serum albumin ≤2.5 g/dL;
  • eGFR ≥30 mL/min/1.73 m2.

You may not qualify if:

  • Body mass index (BMI) ≥40 kg/m2;
  • Low body mass (\<45 kg for female, \<57 kg for male);
  • Acute VTE;
  • Previously introduced anticoagulation (due to comorbidities);
  • Contraindications for enoxaparin;
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Institute of Medicine

Warsaw, Masovian District, 04-141, Poland

Location

Related Publications (1)

  • Matyjek A, Rymarz A, Nowicka Z, Literacki S, Rozmyslowicz T, Niemczyk S. Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome-A Single Center Prospective Study. J Clin Med. 2021 Dec 6;10(23):5709. doi: 10.3390/jcm10235709.

    PMID: 34884411RESULT

MeSH Terms

Conditions

Nephrotic SyndromeVenous Thromboembolism

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Anna Matyjek, MD, PhD

    Military Institute of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 22, 2020

Study Start

October 1, 2015

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

January 30, 2023

Record last verified: 2020-09

Locations

PL(1)